The final rule sets the foundation for the FDA’s science-based regulation of all tobacco products, including e-cigarettes. And retailers have an important role in keeping tobacco products out of the hands of children.
By Mitch Zeller
Tobacco retailers have played a critical role, under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), in keeping cigarettes and smokeless tobacco out of minors’ hands. With the “deeming” rule that extends the Food and Drug Administration’s (FDA) authority to all tobacco products—including e-cigarettes, all cigars, hookah tobacco and pipe tobacco, among others—retailer responsibilities under federal law to keep tobacco products away from kids are likewise expanded.
When it was passed in 2009, the Tobacco Control Act provided the FDA with authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless.
But it also granted the agency the authority to “deem” other tobacco products to be subject to the tobacco product authorities in the Federal Food, Drug and Cosmetic (FD&C) Act by regulation. The FDA’s deeming regulation extends the agency’s authority to products that were previously sold without any regulatory review of ingredients, how they were made or potential dangers.
Under the rule, published in May of this year, all manufacturers, importers and retailers will be subject to any applicable provisions of the FD&C Act and FDA regulations. The rule is foundational, laying the groundwork for additional science-based regulation aimed at reducing tobacco products’ toll in this country.
NO SALE UNLESS 18
The rule’s provisions prohibiting sales of covered tobacco products to minors are among those most relevant to convenience stores and other retail outlets. Before this rule, no federal law prohibited retailers from selling e-cigarettes, hookah tobacco and cigars to minors. Now, retailers may not sell these products, either in person or online, to those under age 18 (starting on the rule’s Aug. 8, 2016, effective date). Further examples of requirements for retailers of such products under the rule include:
- Must verify age with a photo ID for anyone under the age of 27;
- May not sell the products in vending machines (unless in an adult-only facility); and
- May not provide free samples.
These provisions are designed to address worrying trends in youth tobacco use, and in turn protect children from a lifetime of nicotine addiction. One example of an alarming trend, a study supported by the FDA and the Centers for Disease Control and Prevention showed that use of e-cigarettes among high school students skyrocketed by about 900% in recent years, from 1.5% in 2011, to 16% in 2015.
Age restrictions are not unfamiliar territory for tobacco retailers, given that sales of cigarettes and smokeless tobacco have been age-restricted for years. And, age restrictions represent common ground between the FDA and retailers.
The National Association of Convenience Stores (NACS) and the National Association of Tobacco Outlets (NATO) have expressed support for a minimum age of 18 years old — and a requirement of age verification by photo ID—for the sale of a wide range of tobacco products, including e-cigarettes.
ROOM FOR IMPROVEMENT
Historically, most retailers have complied with the law and regulations. We applaud the many tobacco retailers that have taken their compliance responsibilities seriously. However, there are still retailers who continue to sell tobacco products to kids. The public health would benefit greatly from a re-commitment among tobacco sellers to ensure they comply with these regulations for all tobacco products.
This becomes even more important given the popularity of e-cigarettes with young people.
While we are aware of the problems linked to young people being provided tobacco products through social sources, the fact remains that retailers have a critical responsibility to comply with the federal prohibition on sales to minors.
OPEN COMMUNICATION
The FDA is committed to keeping the lines of communication open with retailers and other industry stakeholders, and to respectfully consider different points of view.
To help retailers understand the deeming rule and how to comply with it, the FDA has a wide array of materials available. Please visit the FDA Center for Tobacco Products’ Retail Information Page. This page includes regulation documents, compliance training webinars, deeming summaries for retailers, webpages for each type of tobacco product the FDA regulates, and CTP’s Office of Small Business Assistance.
Mitch Zeller is the director of the FDA’s Center for Tobacco Products
